Wednesday, October 26, 2016

Phase III study established equivalence in efficacy and similar safety
profile between BI 695501 and Humira® (adalimumab) in patients with
active rheumatoid arthritis (RA) Results pave the way for submitting BI 695501 for regulatory approval in key markets

“This milestone paves the
way for submitting BI 695501 for regulatory approval in key markets such
as the USA and Europe”, said Sandeep Athalye, MD, Vice President and
Head, Clinical Development and Medical Affairs Biosimilars, Boehringer
Ingelheim. ”With our focus on BI 695501 and other biosimilar candidates,
we recognize biosimilars as playing an increasing role in providing
patients and doctors with high quality therapeutic options while
contributing to the long term sustainability of healthcare systems.”

This
Phase III clinical study was a randomized, double-blind, parallel arm,
multiple dose, active comparator study1 in 645 patients diagnosed with
moderate to severe active rheumatoid arthritis who were treated with
methotrexate. Each participant was randomized to receive either BI
695501 or Humira® every two weeks for 48 weeks. The primary objective of
this clinical study was to establish statistical equivalence in
efficacy between BI 695501 and Humira® in patients with active RA as
measured by the proportion of patients meeting ACR20 (American College
of Rheumatology 20) criteria at Week 12 and at Week 24 compared to
baseline.2

The secondary objectives of this clinical study were
to compare other efficacy parameters (DAS28)3, safety and immunogenicity
of BI 695501 and Humira®.

Results from this clinical study will be published and presented at future medical congresses.

Intended audiences:

This
press release is issued from our Corporate Headquarters in Ingelheim,
Germany and is intended to provide information about our global
business. Please be aware that information relating to the approval
status and labels of approved products may vary from country to country,
and a country-specific press release on this topic may have been issued
in the countries where we do business.

For references and notes
to editors, please visit:
http://www.boehringer-ingelheim.com/press-release/boehringer-ingelheim-s-adalimumab-biosimilar-candidate-shows-similar-efficacy-and